Evaluation of Brain Damage Due to Coronary Angioplasty in Percutaneous Intervention Patients

Coronary Disease Clinical Trial

Official title:

Assessment of Silent Brain Injury in Chronic Total Occlusion Patients With Percutaneous Coronary Intervention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04734587
• Other study ID #: SBI IN CTO INTERVENTION
• Status: Completed
• Start date: January 18, 2019
• Est. completion date: March 25, 2020

Study information

• Verified date: September 2021
• Source: Ondokuzmayis University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study examines the formation mechanism and patient-related factors of silent cerebral infarcts, whose importance has become increasingly recognized in patients undergoing percutaneous coronary intervention.

Description:

This study was produced from the assistant's thesis and was previously accepted as a poster at EuroPCR 2020. We recently completed the full-length article.

This thesis study was supported by Ondokuzmayis University.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: March 25, 2020
• Est. primary completion date: March 25, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• CTO and Non-CTO patients undergoing percutaneous coronary intervention

Exclusion Criteria:

• baseline NSE elevation

• acute coronary syndromes or cardiac surgery within 4 weeks

• patients with a cerebrovascular accident

• intracranial hemorrhage

• and head trauma

• central nervous system tumor

• degenerative central nervous system disorders and neuroendocrine tumors

Related Conditions & MeSH terms

• Coronary Disease
• Silent Stroke

Intervention

Diagnostic Test:
• Blood serum Neuron-specific Enolase measurement
The Silent Brain Injury ratio was compared by measuring the Neuron-specific enzyme level with venous blood sampling from both patient groups before and after percutaneous coronary intervention.

Locations

Country	Name	City	State
Turkey	Ondokuzmayis University	Samsun

Sponsors (1)

Lead Sponsor	Collaborator
Ondokuzmayis University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Baseline Neuron-specific Enolase (NSE) measurement	Baseline NSE measurement to exclude non-PCI dependent brain injury. Elevation of >20 ng/ml was considered as silent brain injury. Patients with basal nse elevation were considered as SBI and excluded from the study.	NSE blood levels were measured 1-2 hours before the procedure.
Primary	Silent Brain Injury diagnosis	NSE blood levels were measured 12-18 hours after the procedure. Elevation of >20 ng/ml was considered as SBI.	12-18 hours after percutaneous coronary intervention